Interventional, randomized, double-blind, placebo-controlled, optional open-label extension trial of Lu AF82422 in participants with Multiple System Atrophy (NCT06706622)

The purpose of this trial is to find out whether a potential new treatment, the trial drug, Lu AF82422, is safe and effective in people living with Multiple Systems Atrophy (MSA). This trial will compare the effects of the trial drug, Lu AF82422, to placebo (inactive medication). Both the trial drug and placebo will be given as an infusion. Whether progression of MSA will be slowed is measured by a rating scale (questionnaire). The trial will also measure the amount of trial drug in participants blood and cerebrospinal fluid. Participants must have a reliable caregiver who will be available throughout the trial to complete caregiver observer questionnaires when carer/observer-reported outcomes are performed. The trial comprises 2 major periods: a 72-week double-blind PCP and an optional dose-blinded 72 week OLE period.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Kelly Bertram

Key inclusion data

The participant is capable of communicating with the site staff. The participant is able to read and understand the ICF. The participant has signed the trial-specific ICF. The participants caregiver is able to read and understand the Caregivers Informed Consent Form. The participants caregiver has signed the Caregivers Informed Consent Form. The participant is >/=40 and <=75 years of age at the Screening Visit.